510(k) K170093
K170093 is an FDA 510(k) premarket notification submitted by Orthoaccel Technology, Inc. for the device "AcceleDent Optima". The FDA issued a decision of Substantially Equivalent on May 26, 2017. The device falls under product code OYH (Orthodontic Vibratory Accessory), a Class II device regulated under 21 CFR 872.5470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2017
- Date Received
- January 11, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Vibratory Accessory
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.